Coronary DiseaseNCT03045601
Diagnostic Accuracy of CT-FFR Compared to Invasive Coronar Angiography With Fractional Flow Reserve
A study testing CT-FFR and Stress echocardiography in people with Coronary Disease, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Invasive coronary angiography is currently considered gold standard in the assessment of coronary artery disease although the method has limitations. Most importantly invasive angiography only depicts coronary anatomy without determining its physiological significance i.e the likelihood that the stenosis impedes… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- CT-FFR and Stress echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteNorway
- Study dates
- 21 Feb 2017to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proven stenosis by CCTA that require further investigation with invasive coronary angiography i.e. patients with estimated stenosis ≥30- 50%.
- Informed consent
Who cannot join
- Patients with unstable coronary artery disease.
- Previously treated with PCI or coronary surgery.
- Severe renal impairment i.e. GFR <30ml / min
- Contrast allergy
- Contraindication to adenosine / nitroglycerin / beta-blocker
- BMI> 40
- Patients referred on the basis of technically unsuccessful CTA, motion artifact or similar
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Coronary Computed Tomographic Angiography Derived Fractional Flow Reserve Compared to Invasive Coronar Angiography With Fractional Flow Reserve
Invasive coronary angiography is currently considered gold standard in the assessment of coronary artery disease although the method has limitations. Most importantly invasive angiography only depicts coronary anatomy without determining its physiological significance i.e the likelihood that the stenosis impedes oxygen delivery to the heart muscle. Fractional flow reserve (FFR) is a catheterization technique for assessing the physiological significance of a coronary artery lesion during invasive coronary angiography. Coronary computed tomographic angiography (CCTA) is a noninvasive imaging test that has become an alternative route to diagnosis for patients with suspected coronary artery disease. Computational fluid dynamics combined with anatomical models based on CCTA scans allows determination of coronary flow and pressure, and has emerged as a promising diagnostic modality called CT-FFR. In this Project New Mathematical algorithms are developed for computation of CT-FFR. The main objective of this study is to determine the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve and state-of-the-art dobutamin stress echocardiography.
- Conditions
- Coronary Disease
- Being tested
- CT-FFR, Stress echocardiography
- Keywords
- Diagnostic Techniques, Cardiovascular, Coronary Angiography, Fractional Flow Reserve, Myocardial, Echocardiography, Stress
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-FFRDiagnostic test
Invasive FFR and CCTA With CT-FFR
Stress echocardiographyDiagnostic test
Stress echocardiography and invasive FFR
| Study group | Role | What they receive |
|---|---|---|
| CT-FFR | Experimental | Analyse With New CT-FFR Method Receives: Diagnostic Test: CT-FFR |
| Stress echocardiography | Active comparator | Analyse With invasive FFR and stress echocardiography Receives: Diagnostic Test: Stress echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT- FFR values by New Method as a dichotomous variable
Determining the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve
Measured: 4 weeks
Worsening regional wall motion abnormality
Determining the diagnostic accuracy of invasive FFR with comprehensive stress echocardiographic techniques
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start21 Feb 2017
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Petter Aadahl, MD, PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045601
- Sponsor's protocol ID
- 2016/1609
- Status last verified
- Mar 2020
- First submitted
- 26 Jan 2017
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Braten AT, Fossan FE, Muller LO, Jorgensen A, Stensaeth KH, Hellevik LR, Wiseth R. Automated computed tomography-derived fractional flow reserve model for diagnosing haemodynamically significant coronary artery disease: a prospective validation study. Eur Heart J Imaging Methods Pract. 2024 Sep 30;2(3):qyae102. doi: 10.1093/ehjimp/qyae102. eCollection 2024 Jul.
PubMed 39450294Tjellaug Braten A, Holte E, Wiseth R, Aakhus S. Dobutamine stress echocardiography after positive CCTA: diagnostic performance using fractional flow reserve and instantaneous wave-free ratio as reference standards. Open Heart. 2024 Sep 30;11(2):e002899. doi: 10.1136/openhrt-2024-002899.
PubMed 39349050
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Coronary Computed Tomographic Angiography Derived Fractional Flow Reserve Compared to Invasive Coronar Angiography With Fractional Flow Reserve
- ClinicalTrials.gov ID
- NCT03045601
- Acronym / sponsor ID
- 2016/1609
- Conditions
- Coronary Disease
- Keywords
- Diagnostic Techniques, Cardiovascular, Coronary Angiography, Fractional Flow Reserve, Myocardial, Echocardiography, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Invasive coronary angiography is currently considered gold standard in the assessment of coronary artery disease although the method has limitations. Most importantly invasive angiography only depicts coronary anatomy without determining its physiological significance i.e the likelihood that the stenosis impedes oxygen delivery to the heart muscle. Fractional flow reserve (FFR) is a catheterization technique for assessing the physiological significance of a coronary artery lesion during invasive coronary angiography. Coronary computed tomographic angiography (CCTA) is a noninvasive imaging test that has become an alternative route to diagnosis for patients with suspected coronary artery disease. Computational fluid dynamics combined with anatomical models based on CCTA scans allows determination of coronary flow and pressure, and has emerged as a promising diagnostic modality called CT-FFR. In this Project New Mathematical algorithms are developed for computation of CT-FFR. The main objective of this study is to determine the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve and state-of-the-art dobutamin stress echocardiography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-FFR | Experimental | Diagnostic Test: CT-FFRAnalyse With New CT-FFR Method |
| Stress echocardiography | Active comparator | Diagnostic Test: Stress echocardiographyAnalyse With invasive FFR and stress echocardiography |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Proven stenosis by CCTA that require further investigation with invasive coronary angiography i.e. patients with estimated stenosis ≥30- 50%.
- Informed consent
Key exclusion criteria (7 listed)
- Patients with unstable coronary artery disease.
- Previously treated with PCI or coronary surgery.
- Severe renal impairment i.e. GFR <30ml / min
- Contrast allergy
- Contraindication to adenosine / nitroglycerin / beta-blocker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-FFRInvasive FFR and CCTA With CT-FFR | Diagnostic test | CT-FFR |
| Stress echocardiographyStress echocardiography and invasive FFR | Diagnostic test | Stress echocardiography |
Primary outcome
CT- FFR values by New Method as a dichotomous variable
Time frame: 4 weeks
Determining the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve
Worsening regional wall motion abnormality
Time frame: 4 weeks
Determining the diagnostic accuracy of invasive FFR with comprehensive stress echocardiographic techniques
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Derived from this study: PubMed 39450294Braten AT, Fossan FE, Muller LO, Jorgensen A, Stensaeth KH, Hellevik LR, Wiseth R. Automated computed tomography-derived fractional flow reserve model for diagnosing haemodynamically significant coronary artery disease: a prospective validation study. Eur Heart J Imaging Methods Pract. 2024 Sep 30;2(3):qyae102. doi: 10.1093/ehjimp/qyae102. eCollection 2024 Jul.
- Derived from this study: PubMed 39349050Tjellaug Braten A, Holte E, Wiseth R, Aakhus S. Dobutamine stress echocardiography after positive CCTA: diagnostic performance using fractional flow reserve and instantaneous wave-free ratio as reference standards. Open Heart. 2024 Sep 30;11(2):e002899. doi: 10.1136/openhrt-2024-002899.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petter Aadahl, MD, PhD study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-FFR and Stress echocardiography in people with Coronary Disease, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT- FFR values by New Method as a dichotomous variable (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03045601, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.